BS EN IEC 63077:2019

This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT's performance, safety specifications, or INTENDED USE according to its original or applicable valid registration.

Cross References:
ISO 13485
EN ISO 13485:2016
ISO 13485:2016
ISO 14971:2007
EN ISO 13485:2016/AC:2018
IEC 61223-2-6:2006
IEC TR 60788:2004
IEC 61675-2:2015
IEC 60601-1:2005
IEC 62353:2014
IEC 60601-2-37:2007
IEC 60601-1:2005/AMD1:2012
EN 60601-1:2006
IEC 60601-1-3:2008
IEC 60601-2-43:2010
EN 62353:2014
IEC 60601-2-33:2010
IEC TR 61948-3:2018


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